Astra Tech Implant System® EV 26372Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Astra Tech Implant EV Profile 4.2 PS - 9 mm OsseoSpeed® · Class 2 · Implant
All models of ASTRA TECH Implant System EV (177)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Astra Tech dental implant has 118 adverse event reports, with 117 injuries and no deaths. Most describe the implant being lost, and many mention bone loss around the implant and infection. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 120
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 07392532214592), received between Jun 21, 2023 and Sep 30, 2026 — classified as 119 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (97 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate97
- Loss of Osseointegration15
- Fracture5
- Insufficient Device Problem Information2
- Material Deformation1
Patient problems
- Failure of Implant118
- Unspecified Infection29
- Osteolysis28
- Inflammation14
- Pocket Erosion11
- Implant Pain4
- Inadequate Osseointegration2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50951918 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection, pain, and swelling.
Patient problems: Implant Pain; Inadequate Osseointegration; Swelling/ Edema; Unspecified Infection
MAUDE report 50671198 ↗InjuryAug 26, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50458215 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Pain and swelling was also reported.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50217316 ↗InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50126965 ↗InjuryJul 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS- OSTEOLYSIS
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25762415 ↗InjuryJul 8, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS ASSOCIATED WITH PERI-IMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25747013 ↗InjuryJun 24, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION, MOBILITY, AND GRADUAL BONE LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 25608964 ↗InjuryJun 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND LOOSENING WITH PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25497515 ↗InjuryJun 11, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. SEVERE BONE LOSS / TRIAL OF TREATMENT BY IMPLANTOPLASTY THEN FINALLY REMOVED UPON OBSERVING FISSURE OF THE NECK.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25477184 ↗InjuryJun 5, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25410274 ↗InjuryJun 5, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25406371 ↗InjuryJun 5, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25406318 ↗InjuryMay 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25233334 ↗InjuryMay 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25233269 ↗InjuryApr 29, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - OSTEOLYSIS, BONE RESORPTION.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25034380 ↗InjuryApr 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24917874 ↗InjuryApr 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24879407 ↗InjuryApr 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24859027 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION, AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 24831675 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION, AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 24831643 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND GRADUAL BONE LOSS.
Patient problems: Failure of Implant
MAUDE report 24831457 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 24831278 ↗InjuryApr 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24829390 ↗InjuryApr 3, 2026Fracture
CUSTOMER REPORTED AN IMPLANT FRACTURE. IMPLANT HAS A CRACK AT THE EDGE.
Patient problems: Failure of Implant
MAUDE report 24780721 ↗
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- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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